EN 556-2:2015
(Main)Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.
Sterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als ''STERIL'' gekennzeichnet werden - Teil 2: Anforderungen an aseptisch hergestellte Medizinprodukte
Diese Europäische Norm legt die Anforderungen an ein aseptisch hergestelltes Medizinprodukt fest, das als „STERIL“ gekennzeichnet wird.
ANMERKUNG Für die Anwendung der EU-Richtlinie(n) für Medizinprodukte (siehe Literaturhinweise) ist die Kennzeichnung eines Medizinproduktes als „STERIL“ gestattet, wenn ein validiertes Sterilisationsverfahren angewandt wurde. Anforderungen an die Validierung und die Routineüberwachung von aseptischen Verfahren sind in
EN ISO 13408-1 festgelegt. Spezielle Anforderungen an aseptischen Verfahren bei festen Medizinprodukten und Kombinations-Medizinprodukten sind in ISO 13408-7 festgelegt.
Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d’obtenir l’étiquetage « STÉRILE » — Partie 2 : Exigences pour les dispositifs médicaux soumis à un traitement aseptique
La présente Norme européenne fixe les exigences à respecter pour qu’un dispositif médical ayant été soumis à un traitement aseptique puisse être étiqueté « STÉRILE ».
NOTE Dans le cadre de la ou des Directives UE relatives aux dispositifs médicaux (voir la bibliographie), l’apposition d’une étiquette « STÉRILE » sur un dispositif médical est admise lorsqu’un traitement de fabrication et de stérilisation validé a été utilisé. Les exigences de validation et de contrôle de routine des procédés aseptiques sont spécifiées dans l’EN ISO 13408 1. Les exigences propres au traitement aseptique des dispositifs médicaux solides et des produits combinés sont spécifiées dans l’ISO 13408 7.
Sterilizacija medicinskih pripomočkov - Zahteve za medicinske pripomočke, ki morajo biti označeni s "STERILNO" - 2. del: Zahteve za medicinske pripomočke, izdelane v aseptičnem okolju
Ta evropski standard določa zahteve za medicinske pripomočke, izdelane v aseptičnem okolju, z oznako »STERILNO«.
OPOMBA: Za namen tega standarda se uporabljajo direktive Evropske unije za medicinske pripomočke (glej razdelek Literatura), ki določajo, da je uporaba oznake »STERILNO« za medicinski pripomoček dovoljena samo na podlagi potrjenega postopka izdelave in sterilizacije. Zahteve za potrditev in rutinsko kontrolo aseptične proizvodnje so določene v standardu EN ISO 13408-1. Posebne zahteve za aseptično proizvodnjo trdnih medicinskih pripomočkov in kombiniranih proizvodov so določene v standardu EN ISO 13408-7 (v pripravi).
General Information
Relations
Frequently Asked Questions
EN 556-2:2015 is a standard published by the European Committee for Standardization (CEN). Its full title is "Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices". This standard covers: This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.
This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408 1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408 7.
EN 556-2:2015 is classified under the following ICS (International Classification for Standards) categories: 11.080.01 - Sterilization and disinfection in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 556-2:2015 has the following relationships with other standards: It is inter standard links to EN 556-2:2003, EN 556-2:2024. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 556-2:2015 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC, 98/79/EC; Standardization Mandates: M/252, M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2015
1DGRPHãþD
SIST EN 556-2:2004
6WHULOL]DFLMDPHGLFLQVNLKSULSRPRþNRY=DKWHYH]DPHGLFLQVNHSULSRPRþNHNL
PRUDMRELWLR]QDþHQLV67(5,/12GHO =DKWHYH]DPHGLFLQVNHSULSRPRþNH
L]GHODQHYDVHSWLþQHPRNROMX
Sterilization of medical devices - Requirements for medical devices to be designated
''STERILE" - Part 2: Requirements for aseptically processed medical devices
Sterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als
''STERIL'' gekennzeichnet werden - Teil 2: Anforderungen an aseptisch hergestellte
Medizinprodukte
Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en
vue d’obtenir l’étiquetage STÉRILE - Partie 2: Exigences pour les dispositifs médicaux
soumis à un traitement aseptique
Ta slovenski standard je istoveten z: EN 556-2:2015
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 556-2
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2015
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN 556-2:2003
English Version
Sterilization of medical devices - Requirements for medical
devices to be designated ''STERILE" - Part 2: Requirements
for aseptically processed medical devices
Stérilisation des dispositifs médicaux - Exigences Sterilisation von Medizinprodukten - Anforderungen
relatives aux dispositifs médicaux en vue d'obtenir an Medizinprodukte, die als ''STERIL'' gekennzeichnet
l'étiquetage " STÉRILE " - Partie 2 : Exigences pour les werden - Teil 2: Anforderungen an aseptisch
dispositifs médicaux soumis à un traitement aseptique hergestellte Medizinprodukte
This European Standard was approved by CEN on 24 July 2015.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 556-2:2015 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 6
4 Requirements . 8
4.1 Validation and routine control . 8
4.2 Compliance . 10
4.3 Documentation and records . 10
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on active implantable medical devices . 11
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices. 12
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices . 13
Bibliography . 15
European foreword
This document (EN 556-2:2015) has been prepared by Technical Committee CEN/TC 204 “Sterilization of
medical devices”, the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall be
withdrawn at the latest by March 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN 556-2:2003.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annexes ZA, ZB and ZC, which are integral parts of
this document.
EN 556, Sterilization of medical devices — Requirements for medical devices to be designated ''STERILE", is
currently composed with the following parts:
— Part 1: Requirements for terminally sterilized medical devices;
— Part 2: Requirements for aseptically processed medical devices [this document].
The following amendments have been made in updating the document from EN 556-2:2003:
a) normative references have been updated;
b) terms and definitions have been aligned with ISO/TS 11139 and EN ISO 13408-1;
c) requirements on validation and routine control have been revised;
d) Table 1 and Table 2 on acceptance limits and actions for occurrence of non-sterile units in process
simulations in initial performance qualification and in periodic requalification, respectively, have
been added;
e) editorial revision according to the CEN Internal Regulations.
Annexes designated ‘informative’ are given only for information. In this standard Annexes ZA, ZB and ZC
are informative.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Introduction
Medical devices designated 'STERILE' are prepared using appropriate and validated methods. Whenever
possible, sterile medical devices are terminally-sterilized using a properly validated and controlled
sterilization process (see EN 556-1, EN ISO 11135, EN ISO 11137-1, EN ISO 14160, EN ISO 14937,
EN ISO 17665-1, EN ISO 20857 and EN ISO 25424). When a medical device is intended to be sterile but
cannot be terminally-sterilized, aseptic processing is the method of manufacture (see EN ISO 13408-1).
Aseptic processing necessitates that either:
a) the entire product is sterilized and then introduced into a sterilized package; or
b) components of the product are sterilized, then further processed/assembled, and the final product
packed into a sterilized package.
Processing/assembly and packaging are carried out in a manner that minimizes the opportunity for items
to become re-contaminated by carrying out these operations in a controlled environment in which
microbial and particulate levels are maintained at or below defined limits and human intervention is
minimized.
NOTE EN ISO 15223-1 specifies the label applied to aseptically processed medical devices as STERILE A.
1 Scope
This European Standard specifies the requirements for an aseptically processed medical device to be
designated 'STERILE'.
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical
device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied.
Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408-1. Specific
requirements for the aseptic processing of solid medical devices and combination products are specified in
ISO 13408-7.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
EN ISO 11135:2014, Sterilization of health-care products — Ethylene oxide — Requirements for the
development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
EN ISO 11137-1:2015, Sterilization of health care products — Radiation — Part 1: Requirements for
development, validation and routine control of a sterilization process for medical devices (ISO 11137-
1:2006, including Amd 1:2013)
EN ISO 13408-2:2011, Aseptic processing of health care products — Part 2: Filtration (ISO 13408-2:2003)
EN ISO 13408-5:2011, Aseptic processing of health care products — Part 5: Sterilization in place
(ISO 13408-5:2006)
EN ISO 13485:2012, Medical devices — Quality management systems — Requirements for regulatory
purposes (ISO 13485:2003)
EN ISO 14160:2011, Sterilization of health care products — Liquid chemical sterilizing agents for single-use
medical devices utilizing animal tissues and their derivatives — Requirements for characterization,
development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
EN ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices (ISO 14937:2009)
EN ISO 17665-1:2006, Sterilization of health care products — Moist heat — Part 1: Requirements for the
development, validation and routine control of a sterilization process for medical devices
(ISO 17665-1:2006)
EN ISO 20857:2013, Sterilization of health care products — Dry heat — Requirements for the development,
validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
EN ISO 25424:2011, Sterilization of medical devices — Low temperature steam and formaldehyde —
Requirements for development, validation and routine control of a sterilization process for medical devices
(ISO 25424:2009)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
aseptic processing
handling of sterile product, containers and/or devices in a controlled environment, in which the air
supply, materials, equipment and personnel are regulated to maintain sterility
[SOURCE: EN ISO 13408-1:2015, 3.4]
3.2
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[SOURCE: ISO/TS 11139:2006, 2.2]
3.3
medical device
instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software,
material or other similar or related article, intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the specific purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
— investigation, replacement, modification or support of the anatomy or of a physiological process,
— supporting or sustaining life,
— control of conception,
— disinfection of medical devices,
— providing information for medical purposes by means of in vitro examination of specimens derived
from the human body
and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
[SOURCE: EN ISO 13485:2012, 3.7]
3.4
performance qualification
PQ
process of obtaining and documenting evidence that the equipment, as installed and operated in
accordance with operational procedures, consistently performs in accordance with predetermined
criteria and thereby yields product meeting its specification
[SOURCE: ISO/TS 11139:2006, 2.30]
3.5
process simulation
exercise that simulates the manufacturing process or portions of the process in order to demonstrate the
capability of the aseptic process to prevent biological contamination
[SOURCE: ISO 13408-7:2012, 3.2]
Note 1 to entry: Other terms for process simulation include media fill, simulated process fill, simulated filling
operation, broth trial, broth fill.
3.6
requalification
repetition of part of validation for the purpose of confirming the continued acceptability of a specified
process
[SOURCE: ISO/TS 11139:2006, 2.40]
3.7
sterility
state of being free from viable micro-organisms
[SOURCE: ISO/TS 11139:2006, 2.45]
3.8
sterile
free from viable microorganisms
[SOURCE: ISO/TS 11139:2006, 2.43]
3.9
terminally-sterilized
condition of a medical device which has been exposed to a sterilization process in a packaged or
assembled form that maintains the sterility of the medical device or a defined portion thereof
[SOURCE: EN 556-1:2001, 3.5]
3.10
test for sterility
technical operation defined in an official Pharmacopoeia performed on product following exposure to a
sterilization process
[SOURCE: ISO/TS 11139:2006, 2.53]
Note 1 to entry: For the purpose of this document, the official Pharmacopoeia that applies is the European
Pharmacopoeia.
3.11
validation
documented procedure for obtaining, recording and interpreting the results required to establish that a
process will consistently yield product complying with predetermined specifications
[SOURCE: ISO/TS 11139:2006, 2.55]
4 Requirements
4.1 Validation and routine control
For an aseptically processed medical device, the following shall apply:
a) the manufacturing environment in which the aseptic process is conducted is specified and records
demonstrating compliance with the specification throughout the conduct of the process are prepared
and maintained;
b) the processes employed to sterilize product, components, equipment and packaging are validated
and rou
...
The standard EN 556-2:2015 delineates critical requirements for the designation of medical devices as 'STERILE' following aseptic processing. This European Standard is pivotal in ensuring that medical devices are manufactured under rigorous conditions that mitigate contamination risks. Its scope is expertly tailored to cover all aspects of aseptically processed medical devices, establishing a clear framework for design, manufacturing, and quality assurance. One of the key strengths of EN 556-2:2015 lies in its comprehensive requirements for validation of the manufacturing and sterilization processes. By mandating that these processes undergo strict validation, the standard enhances the reliability of aseptic processing, promoting patient safety and trust in medical devices. Furthermore, the standard aligns closely with existing frameworks, such as the EU Directive(s), by incorporating relevant references, including EN ISO 13408-1 and ISO 13408-7, which add depth to its guidelines for validation and routine control practices. The relevance of this standard cannot be overstated, particularly in the context of an increasingly regulated medical device industry. As healthcare standards continue to evolve, EN 556-2:2015 offers assurance that manufacturers are adhering to best practices designed to protect patient health. Moreover, the explicit focus on aseptically processed medical devices provides a targeted framework that addresses the unique challenges faced in this area, ensuring both compliance and innovation in sterilization techniques. In summary, EN 556-2:2015 stands out as a fundamental standard for the sterilization of medical devices. Its meticulous specifications regarding validation processes, routine controls, and integration with other ISO standards fortify its role in the healthcare landscape. This standard not only underlines the importance of aseptic processing but also establishes the criteria that must be met for a medical device to confidently be labeled as 'STERILE'.
SIST EN 556-2:2015 표준은 의료기기의 살균 요구 사항을 다루며, 특히 ‘STERILE’로 지정된 무균 가공 의료기기와 관련된 요건을 명확히 규정하고 있습니다. 이 표준은 유럽 연합의 의료기기 지침에 부합하여, 검증된 제조 및 살균 과정을 통해 의료기기가 ‘STERILE’로 지정될 수 있도록 허용하는 내용을 포함하고 있습니다. EN 556-2:2015의 주요 강점은 무균 가공의 구체적 요구 사항을 정의함으로써 제약회사와 제조업체들이 공신력을 갖춘 의료기기를 제공할 수 있도록 방향을 제시한다는 점입니다. 이로 인해 의료기기 사용자의 안전을 높이고, 감염 예방에 기여할 수 있는 기준이 마련되었습니다. 또한, EN ISO 13408 1 및 ISO 13408 7과의 연계성을 통해 무균 과정의 검증 및 정상적인 관리 요구 사항을 포괄적으로 다루고 있어, 의료기기 제조 및 품질 관리에 대한 신뢰성을 강화하는 데 중요한 역할을 하고 있습니다. 또한, 이 표준의 적용은 의료기기 산업에서의 무균 처리 공정에 대한 글로벌 기준을 정립하는 데 크게 기여하며, 이를 통해 시장 경쟁력을 높이고 환자의 안전 및 건강을 증진시키는 데 중요한 영향을 미칩니다. 이러한 측면에서 EN 556-2:2015는 의료기기 관련 산업에 필수적으로 요구되는 기준이자, 무균 처리의 중요성을 강조하는 문서로서의 역할을 충실히 수행하고 있습니다.
Die Norm EN 556-2:2015 legt die spezifischen Anforderungen fest, die erfüllt sein müssen, damit ein medizinisches Gerät als „STERIL“ gekennzeichnet werden kann, sofern es aseptisch verarbeitet wurde. Diese europäische Norm ist von großer Relevanz für Hersteller von medizinischen Geräten, da sie die erforderlichen Schritte zur Gewährleistung der Sterilität definiert und somit das Vertrauen von Fachleuten im Gesundheitswesen stärkt. Ein entscheidender Vorteil der Norm ist die detaillierte Festlegung der Validierungsanforderungen für Prozesse, die zur Sterilisierung führen. Die Norm unterstützt die Einhaltung der EU-Richtlinien für medizinische Geräte, indem sie klare Leitlinien für die Implementierung eines validierten Herstellungs- und Sterilisierungsprozesses bietet. Darüber hinaus verweist sie auf EN ISO 13408-1, die spezifische Anforderungen für die Validierung und routinemäßige Kontrolle aseptischer Prozesse enthält, was die Norm für die Industrie besonders wertvoll macht. Besonders hervorzuheben ist auch die Flexibilität von EN 556-2:2015 in der Anwendung auf verschiedene Arten von medizinischen Geräten, einschließlich fester medizinischer Geräte und Kombinationsprodukten, wie sie in ISO 13408-7 beschrieben sind. Dies ermöglicht den Herstellern, die Norm auf eine breite Palette von Produkten anzuwenden und somit die Qualität und Sicherheit ihrer Geräte zu gewährleisten. Zusammenfassend lässt sich sagen, dass die Norm EN 556-2:2015 eine unverzichtbare Grundlage für die Sicherheit von aseptisch verarbeiteten medizinischen Geräten bietet, indem sie klare Anforderungen definiert und gleichzeitig sicherstellt, dass die Hersteller in der Lage sind, die notwendigen Validierungsprozesse durchzuführen, um die Sterilität ihrer Produkte zu garantieren.
La norme EN 556-2:2015 constitue un cadre essentiel pour l'évaluation et l'assurance de la stérilité des dispositifs médicaux traités par des procédés aseptiques. Son champ d'application est clairement défini, stipulant que cette norme est à suivre pour désigner un dispositif médical comme étant 'STERILE'. Cela est d'une importance capitale dans le domaine des dispositifs médicaux, où la sécurité et l'intégrité des produits sont primordiales pour la santé des patients. Parmi les forces de cette norme, on note son exigence de validation d'un processus de fabrication et de stérilisation avant qu'un dispositif médical puisse prétendre à la désignation 'STERILE'. Cela garantit que les fabricants respectent des protocoles rigoureux, ce qui est essentiel pour prévenir les infections et garantir la sécurité des interventions médicales. L'intégration des exigences de validation et de contrôle routinier des processus aseptiques dans EN ISO 13408-1 renforce encore davantage la validité de ces directives. De plus, EN 556-2:2015 présente des spécificités pour le traitement aseptique des dispositifs médicaux solides et des produits combinés, tel que mentionné dans ISO 13408-7, ce qui montre l’adaptabilité et la pertinence de la norme pour divers types de dispositifs médicaux. En effet, son approche détaillée et sa structuration assurent que les organismes de réglementation, ainsi que les fabricants, disposent d'un cadre complet pour garantir la stérilité, ce qui est un atout indéniable pour la mise en œuvre des exigences légales en matière de sécurité des dispositifs médicaux. En somme, la norme SIST EN 556-2:2015 est d'une grande importance pour l'industrie des dispositifs médicaux, fournissant un ensemble de règles précises et rigoureuses qui garantissent que les produits sont véritablement stériles et fiables pour une utilisation clinique.
SIST EN 556-2:2015は、医療機器の滅菌に関する重要な標準であり、特に「STERILE」と指定された医療機器の要件について鋭い焦点を当てています。この標準の範囲は、無菌的に処理された医療機器が「STERILE」として指定される際の要件を明確に規定し、製造と滅菌プロセスが適切に検証されたことを確保します。 この標準の強みは、明確な要件を提供することで、医療機器の安全性と効果を保証する点にあります。無菌的処理に関する要件は、医療機器が使用される環境において感染のリスクを軽減するために不可欠です。さらに、EN 556-2:2015は、EN ISO 13408-1により、無菌プロセスの検証および日常的な管理に関する要求事項を明示しています。これにより、製造者は適切なプロセスを遵守し、製品が「STERILE」として適切に評価されることを確実にするための道筋が示されています。 また、固形医療機器や組み合わせ製品に対する無菌処理の特定要件をISO 13408-7が設けていることも、この標準の関連性を高めています。これにより、多様な医療機器に対する無菌処理の基準が一貫性を持ち、医療分野における信頼性を向上させています。 全体的に見ると、SIST EN 556-2:2015は、医療機器が「STERILE」として適切に製造され、管理されるための重要なガイドラインを提供し、医療の質の向上に寄与しています。この標準は、製造業者や医療従事者にとって、有用かつ必要不可欠なリソースであるといえます。
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